Validation of a Procedure for Potency Assessing of a High Purity Factor VIII Concentrate -Comparison of Different Factor VIII Coagulant Assays and Effect of Prediluent

Claudine Mazurier; Armelle Parquet-Gernez; Maurice Goudemand

doi:10.1055/s-0038-1647295

Thrombosis and Haemostasis, Inhaltsverzeichnis

Thromb Haemost 1990; 64(02): 251-255
DOI: 10.1055/s-0038-1647295

Original Article

Schattauer GmbH Stuttgart

Validation of a Procedure for Potency Assessing of a High Purity Factor VIII Concentrate -Comparison of Different Factor VIII Coagulant Assays and Effect of Prediluent

Claudine Mazurier

The Centre Régional de Transfusion Sanguine de Lille, France

,

Armelle Parquet-Gernez

The Centre Régional de Transfusion Sanguine de Lille, France

,

Maurice Goudemand

The Centre Régional de Transfusion Sanguine de Lille, France

› Institutsangaben

Abstract

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Summary

The assessment of factor VIII coagulant activity (FVTII: C) in recently available highly purified and concentrated FVTII therapeutic products calls for careful evaluation of assay methodologies. We assayed more than 130 batches of a concentrate with a specific activity of about 150 FVTII :C units/mg protein, using one-stage and two-stage clotting and chromogenic methods. There was good agreement between the potency estimates obtained with the different methods. We also compared the FVTII :C potencies obtained after predilution in buffer or FVIII-deficient plasma using either calibrated plasma or FVTII concentrate as references. With the one-stage assay we found a marked discrepancy between the potency values obtained with buffer and with FVTII-deficient plasma used as prediluents. In order to validate our “in vitro” data we performed 6 “in vivo” analyses in severe haemophilia A patients. On the basis of the overall data obtained we chose to label FVIII potency by using FVIII-deficient plasma as prediluent, reference plasma as standard and the chromogenic assay method.

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Referenzen

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